What are the basic elements of informed consent?
The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a). OHRP also has a tips sheet for informed consent available at http://www.hhs.gov/ohrp/humansubjects/guidance/ictips.htm. The regulations require that the following information must be conveyed to each subject: • a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental; • a description of any reasonably foreseeable risks or discomforts to the subject; • a description of any benefits to the subject or to others which may reasonably be expected from the research; • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; • a statement describing the extent, if any, to which confidentiality of records identifying the sub
